According to the requirements for supervision of cosmetics issued
by China Food and Drug Administration, flight inspections were carried out
for cosmetics manufactures holding Cosmetics Production Licenses by provincial/autonomous/municipal FDA, in order to urge enterprises to fully implement the
responsibility of quality and safety, further standardize the production
behavior of enterprises and check the potential safety dangers. The flight
inspection was based on "Double random principles" which means "random
selection of inspection objects or inspectors". The inspection mainly
focused on the storage and use of raw materials, the verification and
maintenance of production equipment, the compliance of the production workshop
and process, and the compliance of cosmetics retention materials.

CIRS summarized the flight inspection results of all local
administration in 2017 for reference of domestic cosmetics manufacturers so
that enterprises can effectively carry out self-inspection.

From the summary table, it can be seen that in 2017, 16
provinces, municipalities and autonomous regions have carried out flight
inspections, and more than 90 cosmetics manufacturers did not meet the
requirements of cosmetics production license. According to the distribution
area of cosmetics production enterprises, it can be analyzed that: the total number
of unqualified cosmetics manufacturers in Fujian, Jiangsu, Jiangxi, Shanghai,
Zhejiang and Shandong provinces is up to 52; As a concentrated area of
cosmetics production enterprises, the local bureau in Guangdong province carried
out two flight inspections in the end of March and November 2017, 4 enterprises
were notified. The flight inspection is mainly based on the Inspection Points
of Cosmetics Production License to check the production problems of production
workshops, management and quality, as well as further to check the compliance,
record and retention materials of recorded products.

Table1.
Summarized results of flight inspection of each local bureau in 2017

Area

The month of inspection

Number
of unqualified cosmetics manufacturers

Summary of main problems

Heilongjiang Province

3

9

3

No cleaning facilities in the production
workshop. 2. No cleaning facilities in the microbiology room, inadequate basic infrastructures. 3. Inadequate material storage facilities 4.
Unreasonable installation of production equipment, And no certificate and
periodic check plan. 5. Incomplete production records, and the product was
not recorded. 6. Irregular setting of sample room, etc.

`Liaoning Province

9

2

1. Lack of files of responsible person for
quality. Academic qualification did not meet the requirement.2. Lab
management problems, lack of environmental control facilities in the microbiology
room. Incomplete original record of inspection. 3. Part of production
equipment without equipment status identification. 4. Equipment calibration
and processing equipment were not properly calibrated. 5. No record to the
purchase of raw material, non-compliance of management. 6. Batch production
instructions were not standardized. 7. No input review, the production record
was inconsistent with the product specification. 8. No batch number from
sales record.

Beijing

9

11

4

1. Organizations and personnel
responsibilities problems. 2. The equipment clean had no
sterilization period. 3. Laboratory raw material was not properly kept, no original
inspection records, no corresponding test equipment, did not indicate the
test method. 4. Storage of materials and products was not regulated. 5. The
condition control facility was not set up for the condition. 6. The actual
operation was not consistent with the production process, the production
process was unreasonable, and the material labeling in the production process
was not standardized. 7. Failed to establish a perfect batch production
record, failed to reasonably calculate the material balance, and failed to
ensure that the products of different batches can be effectively identified.

Tianjin

12

2

1. Organizations and personnel
responsibilities problems. 2. The quality control standard
did not meet the requirement. 3. Raw material was not placed according to the
precautions. 4. No inspection report and quality specification of relevant
materials, and the management books were inconsistent. 5. The record product was
not archived, the record information or the record product was inconsistent
with the actual product.

Hebei province

11

6

1. No inspection report for nipin methyl ester

of raw materials. 2. Incomplete records of
finished products. 3. Temperature and humidity records
in storage are not timely registered. 4. The test report used the hygienic
standard for cosmetics (2007 edition) instead of the 2015 edition; 5.Production
records had a write up trace；6. The skin care water was transported by
pipeline, and it was recommended to improve the regulation of pipeline cleaning.
7. Production record and filling record information was not complete to
reflect material balance. 8. The date of retention was not consistent with
the date of the filling record. 9. The water shop pipe was unmarked. 10. Labeling
card of raw materials in the storage was not complete, the outer packing had
no specific production date (batch number) and the expiration date and
related information of the raw material production enterprise.

1. The quality management
system was not perfect, and there were irregularities. 2. Lack of related
inspection system in production workshop. 3. Cleaning and disinfection of
production equipment was not standard. 4. Production management problems. 5. The
product is not filed as required. 6. The product risk assessment basis was
not regulated, and the risk substance was not identified as required. 7. The
product retention sample did not meet the requirements.

Jiangxi Province

10

6

1. The quality management
department doesnot strictly perform
the duties. 2. The inspectors have no certification. 3. The production
environment was undisciplined. 4. Some of the products failed the test. 5. The
production process records were not standardized and the sanitary conditions
are substandard. 6. Raw material management was not accurate. 7.Production
workshop operation was not standard and so on.

Shanghai

3

2

1. Quality management records were incomplete. 2. The production management
system was not perfect. The production process operation content was not
complete. 3. The recall system did not fulfill well. 4. Material acceptance
and storage was not standardized, and records were not complete.

Zhejiang Province

10

11

12

10

1. The production process did
not meet therequirements. 2. The cleaning of the
workshop was not in accordance with the regulations, the regional setting was
not reasonable, the facilities were not put in place, and the workshop
environment was not tested regularly. 3. Improper use of production equipment.
4. The material storage was improper or exceeds the shelf life, the raw
material quality standard was inconsistent with the actual production. 5. The
raw material supplier was not in the qualified list, the quality management
system was not perfect. 6. The production process records were incomplete and
the archives are incomplete. 7. The cleaning standard was not strict in the
actual production process. 8. The health certificate of the enterprise
production staff had expired. 9. The production process water was not tested
regularly. 10. The approved batch of products had expired and has not been
extended. 11. No complete sales record. 12. No sample room. 13. The raw
material label was incomplete. 14. Not fixed storage areas, waste was not
handled in time.

Shandong Province

5

7

10

1. Production without licensed conditions. 2.Lack of production equipment of wax base
unit. 3. Use of expired raw materials, improper raw material management, raw
material storage was not stored according to the label, materials were in
disorder, the information of the cargo card was not complete or not set up. 4.
The production operation procedure was not perfect. 5. Production environment
was not neat, placed no related equipment. 6. No personnel training program. 7.
The environment in the sample room does not meet the requirements.

Guangdong Province

3

11

4

1. The semi-finished product storage was not Standard. 2. No pathogen detection in labs.
3. The enterprise had batch number coding principle but does not have
relevant document regulation. 4. Quality management problems, the product
production record was incomplete, the test report of water and the original
record were not complete, and the product inspection activity was not carried
out. 5. The production plant and facilities did not meet the requirements of
the specification, and the production environment was not equipped with
environmental monitoring facilities and pest control facilities. 6. Cleaning
and disinfection of production equipment was not in conformity with the
specification. 7. Raw material procurement information was incomplete, and
the identification contents of raw materials, semi-finished products and
finished products were incomplete. 8. The production process was not recorded
completely. 9. The production wastes were not cleaned in time. 10. The
retention sample did not meet the requirements. 11. Material management
identifies inaccuracies, no semi-finished products management system, etc.

Henan Province

4

7

10

11

10

1. Check the company's original and auxiliary
material warehouse, packaging material storage, finished product warehouse,
production workshop, laboratory and company's room, collect enterprise
cosmetics application materials, record data, production, inspection, sales
account and other information. The problems were: Improper use of production workshop, incomplete production record, no
environmental monitoring plan, and imperfect sanitation management system. 2.
Improper material management. 3. The product formulation was inconsistent
with the archival data. 4. The production management was not standardized,
and the inspection and reserve management system was not strictly implemented.
5. The production manager was not familiar with the cosmetics production and
production responsibilities. 6. Product not recorded. 7. The production
workshop environment did not meet the specifications and so on.

Hubei Province

10

3

1. Improper production of waste products, production workshop environment chaos. 2. Production
area set unreasonably, not effective isolation of cross contamination. 3. Production
facilities and equipment were not identified. 4. The raw material
identification did not meet the standard.

Hunan Province

12

1

1. Disinfection of production equipment was not standard. 2. The production records were
incomplete, and the logo was not consistent with the actual input. 3. Use of
raw materials was not standardized, and there was no identification of possible
safety risk substances; 4. The claim on product packaging did not comply with
relevant regulations.

1. The production workshop settings were not standardized, the environmental monitoring was
inconsistent with the records. 2. No long-term maintenance of the production
equipment. 3. Existence of potential risk in raw materials storage. 4. Unreasonable
supplier audit system and no material acceptance system. 5. Nonstandard name
of raw materials. 6. Issues exist in the responsibility of responsible person.
7. No training plan. 8. Nonstandard product retention materials. 9. Nonstandard
production management system, no relevant system, operators were not rigorous; 10. No retention of some products.

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